12 results
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18ms
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Sources: EU EUDAMED, US FDA
ACS APCT REAGENT, MODIFIED
FDA 510(k)
FDA Class 2
·Hematology
AngioSystems Drape
FDA UDI
ANGIOSYSTEMS, INCORPORATED·00816611021903·
Duo Lumbar Interbody Fusion Device
FDA UDI
SPINEOLOGY INC.·M7402926012·Duo, Hyper-Lordotic, 60 x 12mm
Gender Solutions®
FDA UDI
Zimmer, Inc.·00889024205833·
Gender Solutions®
FDA UDI
Zimmer, Inc.·00889024205840·
IL TEST(TM) ALPHA-2-ANTIPLASMIN ASSAY SYSTEM
FDA 510(k)
FDA Class 2
·Hematology
PRECISE CHROMATOGRAPHIC IMMUNOASSAY FOR HCG
FDA 510(k)
FDA Class 2
·Clinical Chemistry
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·January 23, 2013
SPRINT QUATTRO SECURE S
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO, INC.·Product code LWS·December 14, 2010
TENDRIL STS
FDA Adverse Event
Injury
·ST. JUDE MEDICAL, INC., CRMD·Product code NVN·July 10, 2014
PATELLO-FEMORAL JOINT SYSTEM GENDER SOLUTIONS PATELLO-FEMORAL¿ Osteoarthritis, traumatic arthritis, polyarthritis, and/or severe chondrocalcinosis of the patellofemoral joint.
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·March 21, 2018
Gender PFJ FEMORAL COMP, prosthesis, knee, patello/femorotibial, semi-constrained, uncemented, porous, coated, polymer/metal/polymer various sizes " Osteoarthritis, traumatic arthritis, polyarthritis, and/or severe chondrocalcinosis of the patellofemoral joint. The salvage of previously failed surgical attempts (e.g., arthroscopy, lateral release, cartilage transplantation). History of patellar dislocation or patella fracture. Dysplasia-induced degeneration. This device is intended for cemented use only."
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·March 2, 2016